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Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis

Primary Purpose

Liver Dysfunction

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Mivacurium Chloride
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Dysfunction focused on measuring mivacurium chloramine, patients with liver cirrhosis, muscle relaxation effect

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients volunteered for the clinical research and signed a written informed consent
  • Experimental group patients is cirrhosis of the liver (liver function grade Child - Pugh, grade A) ready to abdominal surgery patients; The control group was no cirrhosis, ready to abdominal surgery patients
  • Aged 18 ~ 60
  • BMI<28kg/㎡
  • The American society of anesthesiologists (ASA) class I ~ II

Exclusion Criteria:

  • Systolic blood pressure ≥180 mm Hg or < 90 mm Hg, diastolic blood pressure ≥110 mm Hg or < 60 mm Hg
  • Serious heart, brain, liver, kidney, lung, endocrine diseases or serious infection
  • Patients with difficult airway (such as Mallampati airway class III, airway abnormalities, etc.)
  • HR < 50 times/min
  • The patient had a history of mental illness or chronic psychiatric drugs, chronic pain medication history
  • History of alcoholism
  • Patients with neuromuscular system disease
  • Has a tendency to malignant hyperthermia
  • The patient used to test drug allergies or other contraindications
  • Over the past 30 days participated in other clinical drug research

Sites / Locations

  • Tangdu hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Mivacurium Chloride by liver dysfunction

Mivacurium Chloride by normal liver function

Arm Description

Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance

Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance

Outcomes

Primary Outcome Measures

TOF ratio

Secondary Outcome Measures

Steward score
Ramsay score
Mivacurium induced time
Clinical duration of action
Total duration of action
Recovery index
Change of the mean arterial pressure (MAP) and heart rate (HR) during pulling out the endotracheal tube period

Full Information

First Posted
May 24, 2015
Last Updated
August 20, 2015
Sponsor
Tang-Du Hospital
Collaborators
Jiangsu Nhwa Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02473601
Brief Title
Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis
Official Title
To Observe Mivacurium Chloramine Muscle Relaxation Effect in the Operation Anesthesia Patients With Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tang-Du Hospital
Collaborators
Jiangsu Nhwa Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Observed the muscle relaxation of mivacurium in patients with liver cirrhosis.Clear of mivacurium in patients with liver cirrhosis without muscle relaxant accumulation and delayed recovery phenomenon
Detailed Description
The liver is an important organ of the body to maintain life activities, material and energy metabolism, and the main organ of biotransformation and elimination of toxic substances and drugs, have many complex functions. Anesthetic drugs mostly through liver transformation and degradation.Liver cirrhosis, liver cancer patients due to abnormal liver dysfunction and liver metabolism, Most of the muscle relaxant prone to muscle relaxant accumulation and delayed recovery of patients with liver cirrhosis. Mivacurium is a new type of non depolarizing muscle relaxants，has the characteristics of rapid onset, short duration of action. Mivacurium can produce similar clinical effect of depolarizing muscle relaxant succinylcholine, and rapidly be blood Che catabolism, Without liver metabolism. It can either as a single vein for medicinal endotracheal intubation, or as maintain continuous intravenous auxiliary anesthesia drug , is a muscle relaxant to shorten the clinical anesthesia recovery period ideal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Dysfunction
Keywords
mivacurium chloramine, patients with liver cirrhosis, muscle relaxation effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mivacurium Chloride by liver dysfunction
Arm Type
Experimental
Arm Description
Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance
Arm Title
Mivacurium Chloride by normal liver function
Arm Type
Other
Arm Description
Mivacurium Chloride 0.2mg/kg,during anesthesia induction. Mivacurium Chloride 6mg/kg/h,during anesthesia maintenance
Intervention Type
Drug
Intervention Name(s)
Mivacurium Chloride
Other Intervention Name(s)
mivacurium, mivacron
Intervention Description
Anesthesia induction: Intravenous injection of midazolam 0.05 mg/kg,Etomidate 0.3 mg/kg,Sufentanil 0.5 g/kg,TOF detection and adjustment of the first twitch height (T1)100%, Mivacurium Chloramine 0.07 mg/kg intraveous injecting in 5 minutes. Anesthesia maintenance: Two groups of sevoflurance 1%~8% inhalation anesthesia plus intravenous infusion of remifentanil 0.05～0.2 µg/kg/min,Mivacurium Chloramine 6mg/kg/h, Appropriate supplementary analgesia dose of sufentanil before skin incision and the abdomen was closed. The two groups were maintained until the Bis value was 40 ~ 60. PetCO2 was 30 ~ 35mmHg. Hemodynamic fluctuations did not exceed 20% of the baseline value.At least 20 minutes before the operation stopping Mivacurium infusion,Before the end of operation 5-10 minutes stopping infusion of remifentanil and sevoflurane.
Primary Outcome Measure Information:
Title
TOF ratio
Time Frame
Time from administration to TOF (T4/T1) values recovered to 90%,an expected average of 25-30 minutes
Secondary Outcome Measure Information:
Title
Steward score
Time Frame
Time from the end of operation to extubation period,an expected average of 15 minutes
Title
Ramsay score
Time Frame
Time from the end of operation to extubation period,an expected average of 15 minutes
Title
Mivacurium induced time
Time Frame
Time from intravenous injection of mivacurium to T1 reached the maximum inhibition time,an expected average of 3-5 minutes
Title
Clinical duration of action
Time Frame
Time from the Mivacurium injection up to recovery from the neuromuscular blockade to 25% of the initial value, an expected average of 12-20 minutes
Title
Total duration of action
Time Frame
Time from the Mivacurium injection up to recovery from the neuromuscular blockade to 95% of the initial value,an expected average of 25-30 minutes
Title
Recovery index
Time Frame
Time between a 25% and 75% recovery from a neuromuscular blockade,an expected average of 6-8 minutes
Title
Change of the mean arterial pressure (MAP) and heart rate (HR) during pulling out the endotracheal tube period
Time Frame
10 minutes before pulling the endotracheal tube, the moment of pulling the endotracheal tube immediately, pull out the endotracheal tube after 5 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients volunteered for the clinical research and signed a written informed consent Experimental group patients is cirrhosis of the liver (liver function grade Child - Pugh, grade A) ready to abdominal surgery patients; The control group was no cirrhosis, ready to abdominal surgery patients Aged 18 ~ 60 BMI<28kg/㎡ The American society of anesthesiologists (ASA) class I ~ II Exclusion Criteria: Systolic blood pressure ≥180 mm Hg or < 90 mm Hg, diastolic blood pressure ≥110 mm Hg or < 60 mm Hg Serious heart, brain, liver, kidney, lung, endocrine diseases or serious infection Patients with difficult airway (such as Mallampati airway class III, airway abnormalities, etc.) HR < 50 times/min The patient had a history of mental illness or chronic psychiatric drugs, chronic pain medication history History of alcoholism Patients with neuromuscular system disease Has a tendency to malignant hyperthermia The patient used to test drug allergies or other contraindications Over the past 30 days participated in other clinical drug research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhao xiaoyong, master
Phone
13792601256
Email
zhaolove120@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhao xiaoyong, master
Organizational Affiliation
Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
sun meiyan, master
Organizational Affiliation
Shanxi Province, Xi'an city Baqiao District Temple Road, No. 1 Tangdu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tangdu hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhao xiaoyong, master
Phone
13792601256
Email
zhaolove120@163.com
First Name & Middle Initial & Last Name & Degree
sun meiyan, master
First Name & Middle Initial & Last Name & Degree
zhang lianhua, master
First Name & Middle Initial & Last Name & Degree
gao changjun, doctor
First Name & Middle Initial & Last Name & Degree
sun xude, master

12. IPD Sharing Statement

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Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis

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